Nozzle

ABSTRACT

The invention relates to a novel douche nozzle suitable for vaginally administering a douche fluid.

RELATED APPLICATIONS

This application is a continuation application of U.S. Ser. No. 899,373which is a divisional of U.S. Ser. No. 08/445,245, filed May 19, 1995,now U.S. Pat. No. 5,695,481.

This invention relates to a novel douche nozzle for use in theapplication of vaginal douche fluids.

Douche products are known and generally comprise a nozzle in the form ofan elongate tubular body made of smooth surfaced material, e.g smoothplastics material, with an opening in their proximal end for entry of adouche fluid, a generally longitudinal channel for the fluid, and one ormore lateral apertures in the walls of the body for outward lateral flowof the fluid during use. Generally such nozzles are attachable at theirproximal end to a squeeze bottle or other container for the fluid, e.g.by a screw thread or other type of convenient connector.

Douche nozzles are for example disclosed in U.S. Pat. No. 3,228,396,U.S. Pat. No. 3,474,788, U.S. Pat. No. 3,968,797, U.S. Pat. No.4,068,662, U.S. Pat. No. 4,133,313, U.S. Pat. No. 4,167,186, U.S. Pat.No. 4,256,107, U.S. Pat. No. 4,309,995, U.S. Pat. No. 4,351,336, U.S.Pat. No. 4,405,306, U.S. Pat. No. 4,519,794 and U.S. Pat. No. 4,894,053.

Known douche nozzles suffer from the problem that the flow rate of fluidout through the apertures has not been optimised. A further problem isthat transfer of fluid from the channel out through the apertures hasnot been optimised, which may cause development of pressure and poorperformance in cleansing. Further it is desirable that the cervix is notirrigated by the douche fluid, and known douche nozzles do not achievethis requirement.

It is an object of this invention to provide an improved douche nozzlewhich to some extent at least overcomes the problems of known douchenozzles. Other objects and advantages of the invention will be apparentfrom the following description.

According to this invention, a douche nozzle suitable for dispensing adouche fluid comprises an elongate tubular body having an externalsurface and an internal substantially longitudinal channel terminatingin an opening at the proximal end of the nozzle suitable for entry intothe channel of a douche fluid, the channel being closed at its distalend, the body having one or more lateral apertures in its wall andcommunicating with the channel to enable fluid flowing along the channelto exit the body, a portion of the external surface of the bodycomprising one or more longitudinally extending recessed grooves havingfluid diverter means, and characterised in that there is more resistanceto fluid flow within the channel than there is resistance to fluid flowout through the apertures.

This characterising feature of the invention contributes to the effectof ensuring that the pressure of the fluid drops as the fluid flows fromthe channel out through the apertures.

Preferably the grooves are of such a size, shape, and orientationrelative to the surface of the nozzle that in use there is lessresistance to fluid flow along the grooves than there is resistance tofluid flow out through the apertures. This too contributes to the effectof ensuring that there is less fluid pressure as the fluid comes intocontact with human tissue.

In a preferred embodiment of the invention the total area of theapertures in the surface of the body is greater than the cross sectionalarea of the longitudinal channel, at least between the opening at theproximal end and the apertures. This contributes to the avoidance of asquirting or jetting effect of the fluid out through the apertures. Forexample the ratio total area of the apertures:cross sectional area ofthe longitudinal channel may be in the range 1.0001:1 to 3:1, suitablybetween about 1.01:1 to 2:1.

These features of the invention assist in reducing the energy orpressure with which the fluid exits the nozzle and contacts the vaginaltissue, and therefore tends to alleviate the abovementioned problemsassociated with overpressurisation. In particular the constructionalfeatures of the nozzle of the invention are such that the resistance tofluid flow pressure is greatest inside the channel, before the fluidcontacts the tissue, thus preventing any build up of pressure as thefluid flows out of the nozzle through the apertures and along thegrooves and as it comes into contact with vaginal tissue during use.Thus an object achieved by the nozzle of the invention is a reduction offluid flow pressure at the interface between the nozzle and the vaginaltissue. Resistance to fluid flow is greatest inside the nozzle, is lessacross the apertures and is reduced again in the grooves, thus ensuringthat little pressure is developed as the fluid contacts the vaginaltissue.

In a preferred embodiment of the invention, the whole or part of theflow of fluid is diverted by the fluid diverter means from a lateralinto a distal to proximal direction. This assists in reducing thetendency of the nozzle to cause irrigation of the cervix, andfurthermore encourages the fluid to flow downwards during use, bothassisting the douching action and contributing to the reduction inpressure as the fluid flows downwards along the grooves. Consequently itis preferred that the apertures are provided toward the distal end ofthe body, suitably in the half of the length of the body closest to thedistal end. Suitably the apertures may be within 0.15 and 0.5,preferably within 0.2 and 0.4, of the distance from the distal end tothe proximal end.

In addition to diverting the flow of fluid into a distal to proximaldirection part of the fluid flow may be diverted into other directions,e.g. tangentially to the surface of the nozzle, or in a plane includingthe longitudinal axis of the nozzle.

In one embodiment of the invention, the flow of fluid is diverted bydiverter means comprising the location of each aperture in the surfaceof the body, and/or by the location of each aperture adjacent to one ormore diverter surfaces which are so profiled and/or positioned that atleast part of the flow encounters the diverter surface is therebydiverted. If the walls of the body are thick enough the diverter meansmay also comprise a profiling of the walls of the apertures.

In a preferred construction of the nozzle, each aperture is located inan area on the proximal side of a diverter surface. In such aconstruction, fluid flowing outwardly through the aperture has a naturaltendency to spread sideways, and the encounter between the flow of fluidand the so-positioned diverter surface diverts the flow into a distal toproximal direction.

Diverter surfaces may also be included which divert the flow of fluidinto the above-mentioned other directions.

The diverter surface may be in the form of a wall structure or surfaceadjacent to the aperture. The wall surface or structure may suitably bein the form of a generally laterally inclined planar or concave(relative to the aperture) surface formed in the surface of the body ofthe nozzle.

In a preferred embodiment of the invention, each aperture is locatedwithin and at the distal end, of a longitudinally extending recessedgroove in the outer surface of the body, the extreme distal end of thegroove comprising a diverter surface in the form of a wall surface. Thelocation of apertures in such grooves further encourages the douchefluid to flow in a distal to proximal direction, i.e. within thegrooves. In addition the location and size of the apertures within thegrooves is an important factor in optimizing the fluid flow pressure, incombination with the channel size and cross sectional area. Theapertures may suitably be at a distance proximally from the extremedistal end of the groove, typically being within about 0.3 of the lengthof the groove from the extreme distal end of the groove.

Apertures may also be located in other positions in the surface of thenozzle.

It has also been found that selection of a particular profile of suchgrooves is important in achieving optimum flow volume, pressure anddirection, and moreover in reducing the tendency for musculature toclose around the nozzle and thereby obstruct the flow of fluid.Therefore suitably the grooves do not extend for the entire length ofthe tubular body, but end about 0.2 to 0.35 of the distance from thedistal end of the tubular body.

Suitably there are between two and ten recessed grooves in the externalsurface of the nozzle. A preferred form of the nozzle has four to eightgrooves. More preferably the nozzle has between four to six grooves,typically four.

A suitable flow rate of douche fluid appears to be about 10 to 40ml/sec, preferably 17 to 20 ml/sec. Therefore in a preferred embodimentof the invention the grooves are relatively deep, suitably having adepth of 0.3 to 0.8, preferably 0.4 to 0.8, of the radius orextrapolated radius of the body, particularly in the vicinity of theapertures, and preferably over a substantial part, e.g 0.75 or more oftheir length. Preferably where such grooves open out onto the outersurface of the body, the proportion of the circumferential perimeter ofthe body taken up by the open tops of the grooves may be 0.4 to 0.8,suitably 0.5 to 0.7, of the perimeter, particularly in the vicinity ofthe apertures. Typically the ratio depth:width of the grooves may beabout 1:1.5-3.0, e.g around 1:2, particularly in the vicinity of theapertures.

Within the generality of the above many specific forms of the inventionwill be apparent to those skilled in the art. A preferred form of thenozzle has from four to twelve apertures, eight being preferred, locatedin the distal half of four respective grooves, the cross section throughthe nozzle over the region occupied by the grooves being generallycruciform, with the angles between the arms of the cross defining thegrooves. In such a nozzle the apertures may be located in the surface ofthe body in a position such that the flow of fluid is diverted into adirection which is substantially parallel to a plane which includes thedirection of two oppositely pointing arms of the cruciform section. Thelongitudinal channel within the body may suitably run along the axiswhere the arms of the cross meet. The longitudinal channel may have acruciform cross sectional shape generally corresponding to the crosssection of the body, or alternatively may have a generally square crosssection, which may have rounded or truncated corners.

The dimensions of the nozzle may be similar to those of known douchenozzles, being determined primarily by anatomical considerations.

Suitably the opening at the proximal end of the nozzle suitable forentry into the channel of a douche fluid may form a connection for acontainer for a douche fluid. The container may be a conventionalsqueeze bottle, and the connection may comprise a conventional screwthread or snap or friction fit connection. The nozzle may thereforeterminate in a base part comprising the connection. The part of body ofthe nozzle in the vicinity of the apertures may be of a narrower crosssection than the base part, and the differing cross sections may beaccommodated to each other by shoulders between the base part and thenarrow part of the body. The grooves may be continued into the shouldersand optionally also into the base part, and this may assist the flow ofthe liquid during use.

The nozzle may be made of materials generally used in the manufacture ofdouche nozzles, such as smooth surfaced medically acceptable plasticsmaterials such as polyethylene or polypropylene etc. Conventionalmoulding techniques, e.g. injection or blow moulding techniques can beused for forming the nozzle from such materials. Suitably such polymersmay be treated with or include within their bulk medically acceptablelubricants, particularly lubricants which become slippery when they arewetted.

The invention will now be described by way of example only withreference to the accompanying drawings, which are intended to beillustrative of but not limiting the generality of the above disclosure.

FIG. 1 Shows a generalised side view of a nozzle of the invention.

FIGS. 2-5 Show cross sections of the nozzle of FIG. 1 respectively atlongitudinal positions A—A, B—B, C—C and D—D.

FIG. 6 Shows a more detailed part cut away longitudinal sectional viewof the nozzle of FIGS. 1-5

FIG. 7 Shows a more detailed view of the nozzle of FIGS. 1 to 6.

FIG. 8 Shows a longitudinal sectional view through another nozzle of theinvention.

FIG. 9 Shows a generalised side view of the nozzle of FIG. 8

FIGS. 10-13 Show cross sections of the nozzle of FIGS. 8 and 9respectively at longitudinal positions A—A, B—B, C—C and D—D.

FIG. 14 Shows a longitudinal section view through another nozzle of theinvention.

FIG. 15 Shows a longitudinal section view through the nozzle of FIG. 14perpendicular to FIG. 14.

FIG. 16 Shows a generalised side view of the nozzle of FIGS. 14 and 15.

FIGS. 17-21 Show cross sections of the nozzle of FIGS. 14 and 15respectively at longitudinal positions A—A, B—B, C—C, D—D and E—E.

Referring to FIGS. 1 to 7, a nozzle (1 generally) is shown. The nozzle(1) comprises a generally tubular body (2) having a smoothly roundeddistal end (3) and a proximal end (4) having an opening with an internalscrew thread fitting (5) within a base part (6) of the nozzle suitablefor connecting the proximal end (4) to a squeeze bottle (not shown).Internally along the central longitudinal axis of the body (2) is achannel (7), running from the opening at the proximal end (4), to apoint near the distal end (3). The internal outline of the channel (7)in FIG. 1 is shown by a dotted line.

In the body (2) of the nozzle are eight apertures (8), communicatingwith the channel (7) thereby permitting fluid flowing along the channel(7) from the proximal end (4) to the distal end (3) to exit the nozzle.The apertures (8) are located in the half of the length of the body (2)closest to the distal end (3), and are symmetrically disposed in twosets each of four apertures around the longitudinal axis of the body(2).

Each of the apertures (8) is located at the extreme distal end of alongitudinally extending recessed groove (9) in the outer surface of thebody (2), the grooves (9) running longitudinally from this extremedistal end to a region (10) on the outer surface of the base part (6) ofthe body (2) near the proximal end (4). The extreme distal end of eachgroove (9) comprises a wall surface (11), in the form of a generallylaterally inclined concave (relative to the aperture) surface formed inthe surface of the body of the nozzle, immediately proximally adjacentto each aperture (8). The tubular body (2) of the nozzle has a narrowercross section than the base part (6), and the cross section of the body(2) and base part (6) are accommodated by shoulders (12). The grooves(9) extend into the shoulders (12).

The grooves (9) are defined by a generally cruciform cross section ofthe body (2) in the region of the body (2) occupied by the grooves (9)as shown in FIGS. 2 to 5 by the cross sections at the longitudinalpoints A—A, B—B, C—C and D—D respectively, the grooves (9) being definedby the angle between the arms (13) of the cruciform shape. The depth (d)of each groove (9) is around 0.5 of the extrapolated radius (r) of thebody (2), and the proportion of the circumference of the body (2) overthe region of the body (2) occupied by grooves (9) is about 0.6.

The cross sectional shape of the internal channel (7) conforms generallyto the cross sectional shape of the cruciform-sectioned region of thebody (2) occupied by the grooves (9).

In the vicinity of the apertures (8) the area of the apertures (8) isgreater than the cross sectional area of the channel (7).

Referring to FIGS. 8 to 21, parts generally corresponding inconstruction and function to parts of the nozzle of FIGS. 1 to 7 arenumbered correspondingly. Although the overall construction of thenozzle of FIGS. 8 to 21 is similar to that of FIGS. 1 to 7, theapertures (8) are not immediately adjacent to the extreme distal end(11) of the grooves (9) but are at a distance proximally therefrom,typically being within about 0.3 of the length of the groove (9) fromthe extreme distal end of the groove (9). The sections shown in FIGS. 11and 20 are enlarged to show that the apertures are located in thesurface of the body in a position such that the flow of fluid isdiverted into a direction which is substantially parallel to a planewhich includes the direction of two oppositely pointing arms (13) of thecruciform section. In the vicinity of the apertures (8), i.e. at thesection points shown in FIGS. 11 and 20 the ratio total area of theapertures:cross sectional area of the longitudinal channel, being about2:1 in FIGS. 8 to 13 and about 1.07:1 in FIGS. 14 to 21. As shown inFIGS. 10 and 20 the grooves (9) have a depth of about 0.4 of theextrapolated radius of the body (2) in the vicinity of the apertures(8). In the nozzle of FIGS. 14 to 21 the body 2 has an overall proximalto distal taper.

The dimensions of the nozzle shown in FIGS. 1 to 21 may be substantiallythe same as conventional nozzles, the overall length being about 12 cm,with a diameter at a median point, e.g the section B—B of FIG. 8 ofabout 12.5 mm, and an internal diameter at the screw fitting (5) ofabout 20 mm. Other dimensions of the nozzle illustrated may bedetermined empirically.

In use, a squeeze bottle (not shown) containing douche fluid is attachedto the open proximal end (4) via the screw thread at (5). The body (2)is then inserted for use, and the douche fluid (not shown) is introducedinto the channel by squeezing the bottle (not shown). Douche fluid exitsthrough the apertures (7) and undergoes a pressure drop as the area ofthe apertures (8) is greater than the cross sectional area of thechannel (7) in the vicinity of the apertures (8). The fluid alsoencounters the diverter surfaces (11) formed by the distal ends of thegrooves (9) and as a result the flow is thereby diverted into a distalto proximal direction. The deep grooves (9) further encourage the fluidto flow in this direction, and the relative depth (d) of the grooves (9)prevents surrounding tissue from obstructing the flow of douche fluid inthe distal to proximal direction. The continuation of the grooves (9)into the shoulder (12) and base region (6) assists drainage during use.

What is claimed is:
 1. A douche nozzle suitable for dispensing a douchefluid comprising an elongate tubular body having proximal and distalends, an external surface and an internal, substantially longitudinalchannel terminating in an opening at the proximal end of the nozzlesuitable for entry into the channel of a douche fluid, the channel alsohaving proximal and distal ends and being closed at its distal end, thebody having at least one lateral aperture in its wall and communicatingwith the channel to enable fluid flowing along the channel to flow fromthe body laterally relative to the direction of elongation of the body,a portion of the external surface of the body comprising at least onelongitudinally extending recessed groove, each lateral aperture beingarranged to direct fluid laterally into one said groove, the nozzle alsoincluding fluid diverter means, comprising a diverter surface,positioned adjacent to each lateral aperture so that it is encounteredby lateral flow of fluid through the aperture, for diverting saidlateral flow of fluid to flow toward the proximal end of the tubularbody.
 2. A douche nozzle according to claim 1 wherein the grooves are ofsuch a size, shape, and orientation relative to the surface of thenozzle that in use there is more resistance to fluid flow out throughthe apertures than there is resistance to fluid flow along the grooves.3. A douche nozzle according to claim 1 wherein the total area of theapertures in the surface of the body is greater than the cross sectionalarea of the longitudinal channel, at least between the opening at theproximal end and the apertures.
 4. A douche nozzle according to claim 1wherein at least part of the flow of fluid is diverted by the fluiddiverter means from a lateral into a distal to proximal direction.
 5. Adouche nozzle according to claim 1 wherein the elongate tubular body hasa length, a first half of which extends from the proximal end to anintermediate location midway between the proximal and distal ends, and asecond half of which extends from said intermediate location to thedistal end, and wherein the apertures are provided in said second halfof the length of the body.
 6. A douche nozzle according to claim 1wherein in addition to diverting the flow of fluid into a distal toproximal direction part of the fluid flow is diverted into otherdirections.
 7. A douche nozzle according to claim 1 wherein the divertersurface adjacent to each lateral aperture is constituted, at least inpart, by a profile of the wall of its adjacent aperture.
 8. A douchenozzle according to claim 7 wherein each aperture is located in an areabetween its adjacent diverter surface and the proximal end of theelongate tubular body.
 9. A douche nozzle according to claim 7 whereinthe diverter surface adjacent to each lateral aperture is in the form ofa wall structure.
 10. A douche nozzle according to claim 8 wherein eachaperture is located within, and at the distal end of, one of saidlongitudinally extending recessed grooves, said one of said grooveshaving an extreme distal end comprising a diverter surface in the formof a wall surface.
 11. A douche nozzle according to claim 1 wherein thegrooves do not extend for the entire length of the tubular body, but endabout 0.2 to 0.35 of the distance from the distal end of the tubularbody.
 12. A douche nozzle according to claim 1 having a flow rate ofdouche fluid of about 10 to 40 ml/sec.
 13. A douche nozzle according toclaim 1 wherein the grooves have a depth of 0.3 to 0.8 of the radius ofthe body in the vicinity of the grooves.
 14. A douche nozzle accordingto claim 1 wherein the elongate tubular body has an outer surface havinga circumferential perimeter, and wherein, where the grooves open outonto the outer surface of the body, the proportion of thecircumferential perimeter of the body taken up by the open tops of thegrooves is 0.4 to 0.8 of the perimeter in the vicinity of the apertures.15. A douche nozzle according to claim 1 wherein the number of saidlongitudinally extending recessed grooves is four, each of saidlongitudinally extending recessed grooves has a proximal end and adistal end, a first half of the length of each groove extending from theproximal end of the groove to an intermediate location midway betweenthe proximal and distal ends of the groove, and a second half of thelength of each groove extending from said intermediate location to thedistal end of the groove, and having from four to twelve apertures,located in the distal halves of said four grooves, the cross sectionthrough the nozzle over the region occupied by said grooves beinggenerally cruciform, with the angles between the arms of the crossdefining the grooves.
 16. A nozzle according to claim 15 wherein theapertures are located in the surface of the body in a position such thatthe flow of fluid is diverted into a direction which is substantiallyparallel to a plane which includes the direction of two oppositelypointing arms of the cruciform section.
 17. A douche nozzle according toclaim 1 wherein the opening at the proximal end of the nozzle suitablefor entry into the channel of a douche fluid forms a connection for acontainer for a douche fluid, and the nozzle terminates in a base partcomprising the connection, the part of the body of the nozzle in thevicinity of the apertures having a cross section narrower than the crosssection of the base part, the differing cross sections beingaccommodated to each other by shoulders between the base part and saidpart of the body having a narrower cross section, and the grooves beingcontinued into the shoulders.